BILL NUMBER: AB 556	CHAPTERED  09/28/00

	CHAPTER   796
	FILED WITH SECRETARY OF STATE   SEPTEMBER 28, 2000
	APPROVED BY GOVERNOR   SEPTEMBER 28, 2000
	PASSED THE ASSEMBLY   AUGUST 31, 2000
	PASSED THE SENATE   AUGUST 30, 2000
	AMENDED IN SENATE   AUGUST 28, 2000
	AMENDED IN ASSEMBLY   APRIL 26, 1999

INTRODUCED BY   Assembly Member Davis

                        FEBRUARY 19, 1999

   An act to amend Sections 109890, 109925, 110025, 110110, 110405,
111330, 111355, 111490, and 111610 of, to add Section 110111 to, and
to repeal Sections 110305, 111350, 111405, and 111410 of, the Health
and Safety Code, relating to food and drugs.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 556, Davis.  Drugs and devices:  conformity to federal law.
   Existing law, the Sherman Food, Drug, and Cosmetic Law, contains
provisions regarding the designation, labeling, and advertisement of
drugs and devices, as defined, for sale in the state.  Under existing
law, a violation of any of these provisions is punishable as a
misdemeanor.
   This bill would conform these provisions to the federal Food and
Drug Administration Modernization Act of 1997 with regard to the
regulation of products subject to the federal Food and Drug
Administration jurisdiction.
   Since a violation of the provisions applicable to the sale of
drugs and devices is a crime, this bill would impose a state-mandated
local program.
  The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state.  Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 109890 of the Health and Safety Code is amended
to read:
   109890.  "Antibiotic drug" means any drug , except drugs for use
in animals other than humans, composed in whole or in part of any
form of penicillin, streptomycin, chlortetracycline chloramphenicol,
bacitracin, or any other drug intended for human use containing any
quantity of any chemical substance that is produced by
micro-organisms, and that has the capacity to inhibit or destroy
micro-organisms in dilute solution, including a chemically
synthesized equivalent, or any derivative thereof.
  SEC. 2.  Section 109925 of the Health and Safety Code is amended to
read:
   109925.  "Drug" means any of the following:
   (a) Any article recognized in an official compendium.
   (b) Any article used or intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in human beings or
any other animal.
   (c) Any article other than food, that is used or intended to
affect the structure or any function of the body of human beings or
any other animal.
   (d) Any article used or intended for use as a component of any
article designated in subdivision (a), (b), or (c) of this section.
   The term "drug" does not include any device.
   Any food for which a claim (as described in Sections 403(r)(1)(B)
(21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(3) (21 U.S.C. Sec. 343(r)
(3)) or Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403
(r)(5)(D) (21 U.S.C. Sec.  343(r)(5)(D)) of the federal act), is made
in accordance with the requirements set forth in Section 403(r) (21
U.S.C. Sec. 343(r)) of the federal act, is not a drug under
subdivision (b) solely because the label or labeling contains such a
claim.
  SEC. 3.  Section 110025 of the Health and Safety Code is amended to
read:
   110025.  (a) "Substantial evidence" means evidence consisting of
adequate and well-controlled investigations, including clinical
investigations, by experts qualified by scientific training and
experience to evaluate the effectiveness of the drug or device
involved, on the basis that it could be fairly and responsibly
concluded by the experts that the drug or device will have the effect
it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling, proposed
labeling, or advertising of any drug or device.
   (b) If the department determines, based on relevant science, that
data from one adequate and well-controlled clinical investigation,
and confirming evidence, obtained prior to or after the
investigation, sufficiently establish effectiveness, then the
department may consider that data and evidence, to constitute
substantial evidence for purposes of the preceding sentence.
  SEC. 4.  Section 110110 of the Health and Safety Code is amended to
read:
   110110.  (a) All regulations relating to (1) new drug
applications, except for abbreviated new drug applications, adopted
pursuant to Section 505 of the federal act (21 U.S.C. Sec. 355), (2)
applications for premarket  approval of new devices, adopted pursuant
to Section 515 of the federal act (21 U.S.C.  Sec.  360e), (3)
postmarketing reports, recordkeeping, and other postapproval
requirements for approved new drug applications or approved new
device premarket approval applications, adopted pursuant to the
federal act, that are in effect on January 1, 1993, or that are
adopted on or after that date, shall be the new drug and new device
application regulations of this state.
   (b) The department may, by regulation, adopt any new drug or new
device application regulation that it determines is necessary for the
administration and enforcement of this part, whether or not the
regulation is in accordance with the regulations adopted pursuant to
the federal act.
  SEC. 5.  Section 110305 of the Health and Safety Code is repealed.

  SEC. 6.  Section 110405 of the Health and Safety Code is amended to
read:
   110405.  An advertisement that is not unlawful under Section
110390 is not unlawful under Section 110403 if it is either one of
the following:
   (a) Disseminated only to members of the medical, dental,
pharmaceutical, or veterinary professions, or appears only in the
scientific periodicals of these professions, or is disseminated only
for the purpose of public health education by persons not
commercially interested, directly or indirectly, in the sale of drugs
or devices.
   (b) An advertisement that a drug or device has a specific curative
or therapeutic effect on a condition, disorder, or disease listed in
Section 110403 if the drug or device is approved or cleared for
marketing for that specific curative or therapeutic effect through
any of the following means:
   (1) A new drug application approved pursuant to  Section 111500,
or Section 505 of the federal act (21 U.S.C.  Sec. 355).
   (2) An abbreviated new drug application approved pursuant to
Section 505 of the federal act (21 U.S.C. Sec. 355).
   (3) A licensed biological product pursuant to Section 351 of the
Public Health Service Act (42 U.S.C. Sec. 262).
   (4) A nonprescription drug that meets the  requirements of Part
330 of Title 21 of the Code of Federal Regulations.
   (5) A new animal drug application approved under Section 512 of
the federal act (21 U.S.C. Sec. 360b).
   (6) An abbreviated new animal drug application approved pursuant
to Section 512 of the federal act (21 U.S.C. Sec. 360b).
   (7) A new device application approved pursuant to Section 111550.

   (8) A device premarket approval application approved under Section
515 of the federal act (21 U.S.C. Sec. 360e).
   (9) A determination of substantial equivalence for a device
pursuant to Section 513(f)(1) of the federal act (21 U.S.C. Sec. 360c
(i)).
  SEC. 7.  Section 111330 of the Health and Safety Code is amended to
read:
   111330.  Any drug or device is misbranded if its labeling is false
or misleading in any particular.
  SEC. 8.  Section 111350 of the Health and Safety Code is repealed.

  SEC. 9.  Section 111355 of the Health and Safety Code is amended to
read:
   111355.  (a) Any drug is misbranded unless its label bears, to the
exclusion of any other nonproprietary name except the applicable,
systematic chemical name or the chemical formula, all of the
following information:
   (1) The established name of the drug, if any.
   (2) If it is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including
the kind and quantity or proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein.
   (3) For nonprescription drugs, the quantity or proportion of each
active ingredient and the established name of each inactive
ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of
the federal act (21 U.S.C.  352(e)(1)(A)(ii) and (iii)).
   (b) The requirement for stating the quantity of the active
ingredients of any drug, including the quantity or proportion of any
alcohol, and also including, whether active or not, the quantity or
proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine,
codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain,
strophanthin, strychnine, barbituric acid, or any derivative or
preparation of any substances contained therein, shall apply to all
drugs, including prescription drugs and nonprescription drugs.
However, the requirement for declaration of quantity shall not apply
to nonprescription drugs that are also cosmetics, as defined in
Section 201(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 321(i)) and that are labeled in compliance with federal
labeling requirements concerning declaration of ingredients including
active ingredients and also the quantity and proportion of any
alcohol, except that the quantity or proportion of the following
ingredients, whether active or not, shall be declared:  bromides,
ether, chloroform, acetanilide, acetophenetidin, antipyrine,
atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis,
digitalis glycosides, mercury, ouabain, strophanthin, strychnine,
barbituric acid, or any derivative or preparation of any substances
contained therein.  The department may exempt any nonprescription
drug from the requirement of stating the quantity of the active
ingredients, other than those specifically named in this subdivision,
upon a showing by the applicant through evidence satisfactory to the
department that the granting of the exemption will not endanger the
public health.  For any prescription drug the established name of the
drug or ingredient, as the case may be, on the label and on any
labeling on which a name for the drug or ingredient is used shall be
printed prominently and in type at least half as large as that used
thereon for any proprietary name or designation for the drug or
ingredient.
   The changes made in this section by Chapter 943 of the Statutes of
1978 shall not apply to any drug shipped by a manufacturer or packer
to a retailer or wholesaler before January 1, 1980.  Any such drugs
so shipped shall comply with this section on and after January 1,
1981.
  SEC. 10.  Section 111405 of the Health and Safety Code is repealed.

  SEC. 11.  Section 111410 of the Health and Safety Code is repealed.

  SEC. 12.  Section 111490 of the Health and Safety Code is amended
to read:
   111490.  (a) A drug or device that is subject to Section 111470 is
misbranded if at any time prior to dispensing, its label fails to
bear the statement "Caution:  federal law prohibits dispensing
without prescription," or "Caution:  state law prohibits dispensing
without prescription," or "Rx only."  A drug or device to which
Section 111470 does not apply is misbranded if at any time prior to
dispensing its label bears the caution statement or "Rx only" quoted
in the preceding sentence.
   (b) A device that is subject to Section 111470 is misbranded if,
at any time prior to dispensing, its label fails to bear the
statement "Caution: federal law restricts this device to sale by or
on the order of a ____ ," the blank to be filled in with the
designation of the practitioner licensed to use or order use of the
device.  A device to which Section 111470 does not apply is
misbranded if, at any time prior to dispensing, its label bears the
caution statement quoted in the preceding sentence.
  SEC. 13.  Section 111610 of the Health and Safety Code is amended
to read:
   111610.  Section 111550 does not apply to any of the following:
   (a) A drug or device that is sold in this state, or introduced
into interstate commerce, at any time prior to the enactment of the
federal act, if its labeling and advertising contained the same
representations concerning the conditions of its use.
   (b) Any drug that is licensed under the Public Health Service Act
of July 1, 1944 (58 Stats. 682, as amended; 42 U.S.C. Sec. 201 et
seq.) or under the eighth paragraph of the heading of Bureau of
Animal Industry of the act of March 4, 1913 (37 Stat. 832-833; 21
U.S.C. Sec. 151 et seq.), commonly known as the "Virus-Serum-Toxin
Act."
  SEC. 14.  Section 110111 is added to the Health and Safety Code, to
read:
   110111.  All nonprescription drug regulations and any amendments
to those regulations adopted pursuant to the federal act, that are in
effect on January 1, 2000, or that are adopted on or after that
date, shall be the nonprescription drug regulations of the state.
The department may adopt any nonprescription drug regulation it deems
necessary for the administration and enforcement of this part,
provided that the regulation is not different from, or in addition
to, any requirement for nonprescription drugs pursuant to Section 751
(21 U.S.C. Sec. 379r) of the federal act.
  SEC. 15.  No reimbursement is required by this act pursuant to
Section 6 of Article XIIIB of the California Constitution because the
only costs that may be incurred by a local agency or school district
will be incurred because this act creates a new crime or infraction,
eliminates a crime or infraction, or changes the penalty for a crime
or infraction, within the meaning of Section 17556 of the Government
Code, or changes the definition of a crime within the meaning of
Section 6 of Article XIIIB of the California Constitution.
